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A prospective, multicenter, single-blind, randomized, parallel controlled superiority study evaluating the efficacy and safety of trypan blue eye solution in cataract patients undergoing continuous circular capsulorhexis

A prospective, multicenter, single-blind, randomized, parallel controlled superiority study evaluating the efficacy and safety of trypan blue eye solution in cataract patients undergoing continuous circular capsulorhexis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067353
Enrollment
Unknown
Registered
2023-01-05
Start date
2023-01-05
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

It is used to stain the anterior capsule of lens to distinguish living cells from dead cells

Interventions

Experimental group:Trypan blue eye solution for continuous circular capsulorhexis during cataract surgery
Control group:Non capsule staining routine surgery

Sponsors

Ophthalmology Hospital Affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Over 18 years old (including 18 years old), regardless of gender; 2. Those who are clinically diagnosed with cataract and need to receive phacoemulsification combined with intraocular lens implantation; 3. Patients with cataract disease progressing in accordance with LOCS III classification, lens cortex opacity reaching C4-C5 or nuclear opacity reaching N3 and above; 4. No serious systemic disease; 5. Those who have good compliance and can cooperate to complete the entire clinical trial; 6. Before the start of the study, the subjects are willing and able to sign the informed consent approved by the Institutional Review Board (IRB) and the Ethics Committee (EC) or Ethics Review Board (ERB).

Exclusion criteria

Exclusion criteria: 1. Patients whose pupils cannot dilate to more than 7 mm; 2. Concurrent with other eye diseases, such as glaucoma, high myopia, etc.; 3. Combined with eye infectious diseases, such as dacryocystitis, conjunctivitis, keratitis, etc.; 4. There are serious fundus diseases, such as severe macular degeneration, severe retinal detachment, large fundus hemorrhage or atrophy, etc.; 5. Those who are allergic to trypan blue; 6. Corneal endothelial cell count is less than 2000 /mm2; 7. Pregnant or lactating women; 8. Those who cannot tolerate surgery; 9. Expected poor compliance; 10. Patients who have participated in clinical research of other drugs, biological agents or devices within 3 months; 11. Those who are mentally incompetent or unable to understand the requirements for participating in research; 12. Other investigators consider it inappropriate to participate in the trial. (Note: In order to protect the rights and interests of the subjects, each subject can only enter the trial at one time.)

Design outcomes

Primary

MeasureTime frame
Success rate of continuous annular capsulorhexis;

Secondary

MeasureTime frame
Success rate of intraocular lens implantation in bag;Occurrence rate of posterior capsule rupture;The best corrected visual acuity;

Countries

China

Contacts

Public ContactChen Wei

Ophthalmology Hospital Affiliated to Wenzhou Medical University

1300966353@qq.com+86 137 5772 8118

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026